MAUDE Adverse Event Report: Respironics, Inc. Trilogy100 Ventilator, U.S.A.; Ventilator, Continuous, Facility Use

Model Number	1054260
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of the trilogy 100 ventilator's internal lithium-ion battery is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.The device mentioned in this complaint has exceeded its useful life per the applicable ifu.Therefore, the dhr for this device will not be reviewed at this time.However, the dhr files for this device are available and can be accessed upon specific request.
Event or Problem Description
The manufacturer received information that a trilogy 100 ventilator was returned to a third-party service center for evaluation.There was no patient involvement, and no harm or injury reported.During the device evaluation, a critical, high-priority ventilator service required error code 199- err_vli_ion_failure was noted in the device error log indicating a failure that affects the communication to the batteries and the selection of the power sources.No visible foam particles were noted in the device.No repair was completed on the device; the device was processed as scrap and discarded per local regulations.

• Brand Name: Trilogy100 Ventilator, U.S.A.
• Common Device Name: Ventilator, Continuous, Facility Use
• Manufacturer (Section D): Respironics, Inc.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): Respironics, Inc.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; +1(724)733-0200
• MDR Report Key: 50934118
• Report Number: 2518422-2026-046571
• Device Sequence Number: 9498781
• Product Code: CBK
• UDI-Device Identifier: 00606959015364
• UDI-Public: (01)00606959015364
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Device Lot Number: 130327
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown